In order to enhance the regulation and guidance for the registration of drugdevice combination products, further encourage the marketing of drug-device combination products with clinical value, and build a management mode for drugdevice combination products suitable for China's national conditions, National Medical Products Administration has set the technical evaluation of drug-device combination products as a research project in regulatory science, and organized to formulate the Guideline for Registration Review Drug-Device Combination Products with Device Taking Primary Mode of Action and the Guideline for Registration Review of Qualitative, Quantitative and In Vitro Release Studies of Drugs in Drug-Device Combination Products with Device Taking Primary Mode of Action, which were issued on January 11, 2022.